L.B.
Bohle Formula. Pharma Services GmbH
www.lbbohle-formula.de
The formula for optimal development of medicinal products.
Since 1981, L.B. Bohle Maschinen + Verfahren GmbH has developed and
produced plants and machinery for the pharmaceutical industry.
Since 1995, Formula – Pharmazeutische und chemische Entwicklungsgesellschaft
mbH has developed medicinal products for pharmaceutical companies.
Founded in 2007, L.B. Bohle Formula Pharma Services GmbH merges the core
competencies of plant engineering and construction with research and
development into a qualified partner for pharmaceutical companies.
The L.B. Bohle Service Center located in Ennigerloh provides well-known,
state of the art production equipment for manufacturing solid formulations.
In addition to feasibility-studies, clinical supplies as well as medicinal
products for marketing purposes are manufactured under GMP-conditions.
Quality control and analytical examinations regarding process validation
will be performed by the experts of Formula GmbH. Hence, manufacturing
will be managed by GMP-trained experts of plant and machinery on one
hand, quality control and accompanying analytical testing of processes
will be managed by GMP-trained analysts on the other hand.
Manufacturing and analytical testing under GMP-conditions represent only
one core competency of L.B. Bohle Formula Pharma Services GmbH. Our large
pharmaceutical development service can be used for one single source
from the beginning.
Galenical development starts with analytical development and proceeds
to the validation of the appropriate analytical method. Stability testing
is performed in accordance with ICH-guidance and under GMP-guidelines
for on-going stability. Based on stability protocols, analytical tests
will be performed immediately after removing samples from storage in
large climate-controlled chambers. Therefore, our GMP-lab is equipped
to provide the required analytical service. Each batch will be packaged,
blinded and/or released by qualified personnel at our GMP-facility in
Berlin for the purpose of clinical trials.
Of course you may use our import-service which fulfils the requirement
of §72 AMG, e.g. to provide comparator products from non-EU countries.
After preparing the IMPD and/or CTD or granting the marketing authorisation,
our service for manufacturing, quality control or on-going stability
testing under GMP-conditions is available.
Our highly motivated team will provide on-site process transfer for your
own successful manufacturing of medicinal products, e.g. if manufacturing
procedures should be transferred to home-based machinery, scale up-work
should be necessary or analytical methods have to be transferred (lab-to-lab-transfer).
The cooperation with L.B. Bohle Maschinen + Verfahren GmbH is also presented
on the homepage of
L.B. Bohle-Formula Pharmaceutical Services GmbH
www.lbbohle-formula.de
